Proprioceptive sole or pedal device containing crystals for treatment of statural disorders

ABSTRACT

An article such as a sole or a shoe adapted to contact the sole of a foot, which incorporates at least one crystalline substance which is capable of developing a color in the wavelength range between about 400 nm and 900 nm and stimulates the reflex zones located at the sole of the foot. The method of utilizing such article is also disclosed.

BACKGROUND OF THE INVENTION

(a) Field of the Invention

The present invention relates to medical devices and a therapeuticmethod for the treatment and the prevention of physical troublesassociated with a statural disequilibrium.

(b) Description of Prior Art

A major part of the chronic pains of the back or of the neck are causedby spine disequilibrium. This disequilibrium is clinically associatedwith unbalances or rotations of the pelvic and pectoral girdles.

It has been documented that less than 10% of the population hasperfectly balanced pelvic and pectoral girdles, i.e., an equilibratedspine. Those individuals almost never experience back or neck chronicpain in their life span, and are rarely prone to arthrosis. Constitutiveor acquired unbalances occur in the remaining 90% of the population, inwhom spine curvatures and intervertebral angles are non-physiologic,leading to pain, sequentially at the muscular, articular and ultimatelythe bone level.

Spine disequilibrium may also be responsible for various disorders,including muscular and articular pains, vertigos, lumbagos, arthrosis.The link between these disorders and the spine was established based onobservations that correction of the pelvic and pectoral girdlesunbalances resulted in improvements of the symptoms.

Various therapeutic approaches have been developed to restore the spineequilibrium, and thus alleviate chronic pains in patients. Most of theseapproaches involve the design of pedal devices, mainly soles, since thefeet are the points of normal support of the body in human. In fact, ithas been proven that the feet are the origin of ascending neuralproprioceptive chains that control the tonus of the statural muscularsystem, of which the spine muscles are one component. Adequatestimulations of particular reflex zones located on the sole of the feetinduce a realignment of the ascending proprioceptive chains, and thus are-equilibration of the skeletal muscular system.

This concept has previously been verified by the design of the followingtypes of soles:

soles with micro-reliefs located at the level of the reflex zones of thefoot have been used for several years. However, the routine use of thistype of sole is hampered by the fact that the micro-reliefs have to bevery meticulously adjusted for each patient, and their precise thicknessmust be regularly modified. In addition, they are only active when thepatient is in a standing position.

soles incorporating a polarizing substance, such as a polarizing orpolarizer plate have been described in U.S. Pat. No. 5,158,526. Thesesoles have been marketed in Europe for several years and have been usedfor the correction of statural disorders. However, they exhibit somemajor drawbacks, that limit their routine clinical use. Namely, theyneed to be applied continuously directly at the contact of the skin ofthe foot sole, their efficacy being almost completely abolished whenfabrics such as nylon or stained cotton, found in socks or stockings,are placed between the device and the skin. This continuous applicationinduces increased perspiration in most of the patients, which makes themuncomfortable to wear, resulting in a poor patient's compliance. Inaddition, the lifetime of the active principles of these soles(superposed polarizer plates) is limited to several months, requiring aregular monitoring of the device's efficacy.

a similar kind of soles incorporating at least one flexible filteringfilm with a determined spectral transmission curve have been describedin Canadian patent No. 1,328,734.

Although several case reports have described the efficacy of theaforementioned types of soles, there exist no data from controlledclinical studies performed to establish their clinical usefulness.Despite the fact that anecdotal research, such as case reports, mayprovide some valuable information on the activity of a product, it iswidely recognized by the scientific and medical communities that onlyplacebo-controlled, double blind studies can help to fully objectivelyassess the efficacy and the safety of such a medical device, especiallywhen the parameters used to measure efficacy are essentially clinical,qualitative or semi-quantitative parameters.

Therefore, it is an object of the present invention to provide a pedaldevice, such as a sole, a shoe or another pedal apparatus, that wouldallow to rapidly correct spine disequilibrium, and thus alleviateassociated physical disorders, such as chronic back or neck pains.

It is another object of the invention to provide a type of sole thatcould exert a therapeutic effect when worn under socks or stockings, inorder to prevent patient's discomfort, and therefore improve compliance.

It is also an object of the invention to provide a type of sole, ofwhich the active principles would have a long lifetime, in order toavoid the need for frequent monitoring of the quality of the sole.

It is also an object of the invention to provide a type of sole with aclinical efficacy proven by data resulting from placebo-controlled,double-blind studies.

SUMMARY OF THE INVENTION

The invention relates to a pedal device for treating and/or preventingphysical troubles associated with statural disequilibrium whichcomprises an article adapted to contact the sole of a foot,characterized in that the article incorporates at least one crystallinesubstance having a color by emitting photons in the wavelength rangebetween about 400 nm and 900 nm and stimulating reflex zones located atthe sole of a foot.

The invention therefore has for its object a pedal device, such as asole, a shoe or any other pedal apparatus, preferably incorporating oneor several types of selected crystals such as minerals possibly inpowder form, placed, for example, at designated reflex zones of the footsole.

The invention also relates to a therapeutic method consisting in usingthe aforementioned device to achieve a partial or complete restorationof the spine physiological alignment, and therefore prevent or curephysical disorders associated with spine disequilibrium such asmusculoskeletal pain.

The invention also relates to a therapeutic method consisting in usingthe aforementioned device as a therapeutic agent to improve thecondition of patients suffering from musculoskeletal pain, such aschronic back pain associated or not with spine disequilibrium.

The active principle of the sole or of the pedal device may be acombination of one or several crystalline substances. Both the type andamount of crystalline substances to be used, alone or in combination,are selected based on their ability to stimulate the reflex zoneslocated at the sole of the foot. Although the exact mechanism involvedin alleviating musculoskeletal pains associated or not with spinedisequilibrium and troubles associated with statural disequilibrium isnot well understood, it is believed that these crystalline substancesproduce natural frequencies and radiations which affect the reflexzones. If the crystalline substances are minerals, they cab be mono-,bi-, or multi-atomic, preferably in the form of powders or crystals.They may be selected from the following groups which are listed asillustrative examples:

elements in crystal or powder forms, such as diamond (C), gold (Au),copper (Cu), platinum (Pt), sulfur (S or S₈), silver (Ag), or bismuth(Bi);

natural and synthetic sulphides and sulphosalts in the form of crystalsor powders, such as argentite (AgS), arsenopyrite (FeAsS), arsenictrisulfide (As₂ S₃), proustite (Ag₃ AsS₃), pyrite (FeS₂);

natural and synthetic halides in the form of crystal or powders, such asfluorite (CaF₂) or cryolite (Na₃ AlF₆);

natural and synthetic oxides and hydroxides in the form of crystals orpowders, such as silicon dioxide (SiO₂) derivatives (quartz, jasper,topaz safranite, cornelian, aventurine, amethyst, chalcedony, agate,crystobalite, flint, sand, tridymite) or rutile (TiO₂);

natural and synthetic nitrates, carbonates and borates in the form ofcrystals or powders, such as malachite (Cu₂ [(OH)₂ CO₃ ]), azurite (Cu₃[OH/CO₃ ]), cerusite (PbCO₃);

natural and synthetic sulfates, chromates, molybdates and tungstates inthe form of crystals or powders, such as crocoite (PbCrO₄) or anglesite(PbSO₄);

natural and synthetic phosphates, arseniates and vanadates in the formof crystals or powders, such as apatite (Ca₅ [F(PO₄)₃ ]);

natural and synthetic silicates in the form of crystals or powders, suchas Feldspars (AlSi₃ O₈ and AlSi₂ O₆ derivatives), micas (AlSi₃ O₁₀ andSi₄ O₁₀ derivatives);

natural and synthetic organic substances in the form of crystals orpowders, such as amber (C₁₀ ₁₆ O) or aurin (C₁₉ H₁₄ O₃).

The pedal device according to the invention consists in a pedal supportdevice which may incorporate selected crystals or powders (the activeprinciple). The crystals or powders can be inserted either inside or atthe surface of the device, provided they are at the level of the sole.

The therapeutic method according to the invention consists in applyingthe pedal device, either at one or at both feet of the patient, in orderto induce the expected therapeutic effect. According to this therapeuticmethod, the active principle (e.g., the crystals or powders), possiblydue to the natural frequencies and radiations they give out, exert anon-toxic stimulatory action on the reflex zones located at the level ofthe sole skin, thereby stimulating the proprioceptive ascending chains,and inducing an harmonization of the tonus of the statural muscularsystem. The observed therapeutic effects include the followings:

a rapid re-equilibration of the spine towards normalization of spinecurvatures and intervertebral angles, which can be clinically evidencedby disappearance of unbalances and rotations of the pelvic and scapulargirdles.

the relief of symptoms associated with spine disequilibrium, includingchronic back and neck pains, other muscular and articular pains,vertigos, lumbagos, arthrosis.

the prevention of the occurrence of the aforementioned disordersassociated with spine disequilibrium.

an energetic action, including an increase of physical performances anda diminution of the stress level.

The device according to the invention is notable for the fact that itcan exert its therapeutic effect whether applied directly at the contactof the skin of the foot sole or under socks or stockings, made of anytype of fabric, which improves patient's comfort and compliance. It isalso notable for the fact that its active principle (e.g., the crystalsor powders) have an unlimited lifetime, which eliminates the need tofrequently monitor the quality of the device. In addition, since thecrystals or powders used are naturally occurring on earth, no toxiceffect can result from the energy, frequencies or radiations they giveout.

BRIEF DESCRIPTION OF THE DRAWING

This invention is illustrated by means of the annexed drawings which aregiven only for the purpose of illustration and without restriction. Inthe drawings,

FIG. 1 is an illustration of the rotation of the pectoral and pelvicgirdle;

FIG. 2 is an illustration of the unbalance of the pelvic and pectoralgirdles;

FIG. 3 is a top view of a sole according to the invention includingsulphur powder between the two semi-rigid fabric layers;

FIG. 4 is a longitudinal cross-section view of the sole illustrated inFIG. 3;

FIG. 5 is a top view of a sole according to the invention includingtransverse bands of seven different minerals;

FIG. 6 is a longitudinal cross-section view of the sole illustrated inFIG. 5; and

FIG. 7 is a graph of the Roland and Morris statistical analysis ofpatient's measurements before and after treatment.

DESCRIPTION OF PREFERRED EMBODIMENTS

Two examples of rotations and unbalances are illustrated respectively inFIG. 1 and FIG. 2. FIG. 1 deals with an improper rotation of thepectoral and pelvic girdle and FIG. 2 shows an unbalance of the pelvicand pectoral girdles.

According to a preferred embodiment, the crystalline substance used asactive principle in the pedal device is sulphur in the powder form.According to another preferred embodiment, the active principle is acombination of seven types of crystals or powders, namely red jasper,cornelian, topaz safranite, aventurine, azurite, amethyst and whitequartz. According to another preferred embodiment, the active principleis a combination of sulphur in the powder form and the seven mineralspreviously mentioned in the form of crystals.

According to a highly preferred embodiment, the pedal device is a sole1, in which an amount of 5 mg to 30 g of sulphur powder 3 isincorporated at the level of the arch, between the two semi-rigid fabriclayers 5 and 7 used to manufacture the sole, as shown in FIGS. 3 and 4of the drawings.

According to another highly preferred embodiment the pedal device is asole in which a combination of seven crystals with defined colors (onered, one orange, one yellow, one green, one blue, one purple, and onewhite) is inserted between the two semi-rigid fabric layers used tomanufacture the sole.

According to another highly preferred embodiment, the pedal device is asole 9, in which a combination of seven different crystals or powderswith selected colors (red jasper 11, orange cornelian 13, yellow topazsafranite 15, green aventurine 17, blue azurite 19, purple amethyst 21and white quartz 23) is inserted as seven bands transversely between thetwo semi-rigid fabric layers 25, 27 used to manufacture the sole, asshown in FIGS. 5 and 6 of the drawings.

According to another highly preferred embodiment, the pedal device is asole, in which both the sulphur powder and the combination of the sevencrystals are incorporated.

The present invention will be more readily understood by referring tothe following examples which are given to illustrate the inventionrather than to limit its scope.

EXAMPLE I Effects of soles containing sulphur vs. soles with polarizingPolaroid™ plates on patient's stature: placebo-controlled, double-blindstudies

The goal of this study was to assess the efficacy of sulphur-containingsoles and to compare it to that of soles containing a previouslydescribed (U.S. Pat. No. 5,158,526) active principle, i.e., superposedpolarizing plates. Efficacy was judged clinically by the ability oftested soles to correct unbalances and rotations of the pectoral and thepelvic girdles. In study A, soles were tested immediately at the contactof the feet skin, whereas in study B, soles were tested under socks.Both studies were run in a double-blind fashion vs. a placebo sole, inorder to prevent any subjective component in the course of the clinicalevaluation.

Materials and Methods

Patients

A total of 40 patients (24 in study A and 16 in study B) were includedin the protocols. Selected patients ranged between 18 and 65 years ofage, and had unbalances of the pectoral and of the pelvic girdles, asevidenced in an initial clinical evaluation. None of them had receivedany kind of medical sole in the previous 6 months.

Treatments

Three pairs of soles were designed for the needs of the present studies.The first one was a sole, in which an amount of 50 to 100 mg of sulphurpowder was incorporated at the level of the arch, between the twosemi-rigid fabric layers used to manufacture the sole, according to oneof the preferred embodiment of the present invention. The second one wasa sole made with the active principle (superposed Polaroid™ plates)commercialized by the company Statipro (Marseille, France), according toU.S. Pat. No. 5,158,526. Finally, the third one was a placebo sole,made, as the other test soles, by gluing together two semi-rigid leatherlayers, but with no active principle placed between both layers at thelevel of the arch.

Experimental procedures

Both studies A and B were prospective, placebo-controlled, double-blindstudies. Each selected patient was subjected to 3 consecutive treatmentsin study A and 4 consecutive treatments in study B. Each treatmentconsisted in applying a pair of soles, together with a pair of socks anda pair of shoes to the feet of the patient, according to the followingexperimental plan:

Study A

Treatment 1: placebo sole, in contact with the foot skin

Treatment 2: polarizing sole, in contact with the foot skin

Treatment 3: sulphur sole, in contact with the foot skin

Study B

Treatment 1: placebo sole, under the socks

Treatment 2: polarizing sole, under the socks

Treatment 3: sulphur sole, under the socks

Treatment 4: sulphur sole, in contact with the foot skin

The blindness of the studies was ensured by the following procedures:

the treatments and the clinical evaluation were performed by twodifferent persons, located in different rooms. In these conditions, theclinician performed clinical evaluations on patients wearing shoes andsocks, ensuring the blindness of the clinical examination. In addition,all three types of soles were indistinguishable and coded, so that thetechnician responsible for the treatments could not know the nature ofthe sole he was using. Finally, in each study, all 3 or 4 treatmentswere administered in a random sequence, differing for each patient.

Clinical evaluation

Following each treatment, the patient was subjected to a clinicalevaluation, that included:

pelvic girdle unbalance: detected by a visual examination and apalpation of the pelvis;

pectoral girdle unbalance: detected by a visual examination andpalpation of the shoulders, and quantified by the following test:patient in standing position, both arms dangling, the clinician joinsboth hands and measures the distance (cm) between both forefingers;

pectoral girdle rotation: detected and quantified by the following test:patient in standing position, raises both arms parallel, the clinicianjoins both hands and measures the distance (cm) between bothforefingers.

Statistical Analysis

The relative efficacies of the different treatments within each studywere evaluated by comparing:

1--the effects of the treatments on the number of pelvic girdleunbalances, pectoral girdle unbalances and rotations completelycorrected, by McNemar tests;

2--the effects of the treatments on the intensities of pectoral girdleunbalances and rotations, by an ANOVA analysis of variance for repeatedmeasures. When normality test did not pass, a repeated measure ANOVA onrank was run.

Results

Study A

As shown in Table I, the results revealed that both the polarizing andthe sulphur soles completely resolved a similar number of unbalances androtations when applied at the foot skin contact. Both treatments weresignificantly more efficient than the placebo treatment. However, asillustrated in Table II, the sulphur soles was significantly better thanthe polarizing soles (P<0.05) with respect to their effects on theintensities of the pectoral girdle unbalances and rotations. Namely, thepolarizing soles decreased unbalances and rotations intensities by 61%and 73%, respectively, when compared to the placebo soles, whereassulphur soles decreased unbalances and rotations intensity by 67% and86%, respectively.

Study B

As shown in Tables III and IV, when applied under cotton socks, thepolarizing soles had a very weak effect on statural parameters. Thesesoles did not succeed in completely resolving unbalances or rotationsexcept for 2 pelvic girdle unbalances (Table III). Moreover, theyexhibited a very low potency, decreasing the intensities of pectoralgirdle unbalances and rotations by 15% and 18% respectively. Incontrast, the sulphur soles were equipotent, whether applied under socksor directly applied at the foot skin contact, and reduced theintensities of pectoral girdle unbalances and rotations by 72% and 72%,respectively, when applied under socks (Table IV). When applied undersocks, the sulphur soles were statistically more potent than thepolarizing soles with respect to all measured parameters (Tables III andIV).

In conclusion, the results of both these studies showed that the sulphursoles, which are one of the preferred embodiment of the presentinvention:

1) were more potent than the polarizing soles in improving staturalparameters when applied directly at the contact of the foot skin; and

2) retained their full potency when applied under socks, in contrast tothe polarizing soles, that lost almost completely their activity.

                  TABLE I                                                         ______________________________________                                        Study A: number of unbalances and rotations                                   completely resolved following applications of                                 the tested soles                                                                       pelvic    pectoral   pectoral                                                 girdle    girdle     girdle                                                   unbalances                                                                              unbalances rotations                                       ______________________________________                                        placebo soles                                                                             0 / 24     0 / 24      0 / 24                                     at the skin                                                                   contact                                                                       polarizing 18 / 24 (a) 7 / 24 (a) 13 / 24 (a)                                 soles at the                                                                  skin contact                                                                  sulphur soles                                                                            20 / 24 (a) 8 / 24 (a) 17 / 24 (a)                                 at the skin                                                                   contact                                                                       ______________________________________                                         (a) P < 0.05 when compared to the placebo soles                          

                  TABLE II                                                        ______________________________________                                        Study A: effect of the tested soles on the                                    intensity of pectoral girdle unbalances and                                   rotations (mean ± SEM of 24 patients)                                                 pectoral girdle                                                                           pectoral girdle                                                   unbalances  rotations                                              ______________________________________                                        placebo soles at                                                                           2.06 ± 0.11                                                                              1.60 ± 0.12                                     the skin contact                                                              polarizing soles                                                                           0.81 ± 0.13 (a)                                                                          0.43 ± 0.11 (a)                                 at the skin                                                                   contact                                                                       sulphur soles at                                                                           0.68 ± 0.55 (a,b)                                                                        0.23 ± 0.08 (a,b)                               the skin contact                                                              ______________________________________                                         (a) P < 0.05 when compared to the placebo soles                               (b) P < 0.05 when compared to the polarizing soles                       

                  TABLE III                                                       ______________________________________                                        Study B: number of unbalances and rotations                                   completely resolved following applications of                                 the tested soles                                                                       pelvic    pectoral   pectoral                                                 girdle    girdle     girdle                                                   unbalances                                                                              unbalances rotations                                       ______________________________________                                        placebo soles                                                                             0 / 16     0 / 16     0 / 16                                      under socks                                                                   polarizing  2 / 16     0 / 16     0 / 16                                      soles under                                                                   socks                                                                         sulphur soles                                                                            12 / 16     7 / 16     8 / 16                                      under socks                                                                              (a,b)       (a,b)      (a,b)                                       sulphur soles                                                                            11 / 16     7 / 16     7 / 16                                      at the skin                                                                              (a,b)       (a,b)      (a,b)                                       contact                                                                       ______________________________________                                         (a) P < 0.05 when compared to the placebo soles                               (b) P < 0.05 when compared to the polarizing soles                       

                  TABLE IV                                                        ______________________________________                                        Study B: effects of the tested soles on the                                   intensities of pectoral girdle unbalances and                                 rotations (mean ± SEM of 16 patients)                                                  pectoral girdle                                                                           pectoral girdle                                                   unbalances  rotations                                             ______________________________________                                        placebo soles under                                                                         1.98 ± 0.14                                                                              2.04 ± 0.17                                    socks                                                                         polarizing soles                                                                            1.68 ± 0.14 (a)                                                                          1.68 ± 0.17 (a)                                under socks                                                                   sulphur soles under                                                                         0.56 ± 0.16 (a,b)                                                                        0.58 ± 0.16 (a,b)                              socks                                                                         sulphur soles at                                                                            0.61 ± 0.17 (a,b)                                                                        0.72 ± 0.20 (a,b)                              the skin contact                                                              ______________________________________                                         (a) P < 0.05 when compared to the placebo soles                               (b) P < 0.05 when compared to the polarizing soles                       

EXAMPLE II Effect of crystal-containing insoles on pain and quality oflife in patients with chronic back pain: a randomized placebocontrolled, double-blind study

The objective of this clinical study was to determine the long-termbeneficial effect of crystal-containing insoles in patients with chronicback pain. The tested insoles contained a combination of 8 differentcrystals of minerals as described in the preferred embodiments of thepresent invention.

With regards to the choice of parameters to measure to evaluatetreatment efficacy, there is growing recognition that patientperspectives are essential. Back pain is one of many chronic orrecurrent condition for which cure may be impossible, and improvingquality of life is often the main goal of. therapy. Therefore, weevaluated the effect of a 6-week treatment with the crystal-containinginsoles on patient's quality of life assessed by a validatedquestionnaire, specifically designed to measure self-rated disabilitydue to back pain.

Materials and methods

Patients

A total of 35 patients were included in the protocol. Selected patientsranged between 18 and 65 years of age, and had chronic back pain, whichwas defined as back pain present on at least half of the days in a12-month period in a single or in multiple episodes over the year. Thepatients were included in the study only if they had a score of at least6 in the Roland and Morris questionnaire (see below for description).None of the patients had worn any kind of medical insole in the previous6 months. All the patient gave informed consent to participate in thestudy.

Treatments

The patients were randomly as signed to two treatment groups in a 2:1ratio (2 crystal insoles for 1 placebo sole) . The crystal-containinginsoles were insoles in which a combination of seven different mineralswith selected colors (red jasper, orange corralling, yellow topazsafranite, green aventurine, blue azurite, purple amethyst and whitequartz) was inserted as seven lines transversely between the twosemi-rigid fabric layers used to manufacture the sole, according to thedrawings in FIGS. 5 and 6 of the present invention; in addition, anamount of 50 to 100 mg sulphur powder was placed at the level of thearch, according to FIGS. 3 and 4 of the present invention. The placebosoles were manufactured using the same raw materials, except for thecrystals and sulphur powder, which were substituted by sugar. Bothplacebo and crystal insoles were indistinguishable and coded to ensurethe blindness of the study.

Measures

On the day of inclusion in the study and 6 weeks later, the patientswere asked to fill the Roland and Morris questionnaire, which is avalidated 24-item questionnaire designed to measure self-rateddisability due to back pain (Roland M and Morris R, Spine 8:141-144,1983). In this questionnaire, the score of the patient is defined as thenumber of items for which the patient answers "yes" and ranges thereforebetween 0 (no disability) and 24 (maximum disability).

Statistical analysis

The Roland and Morris scores, measured in each patient before and after6 weeks of treatment were subjected to a two-way ANOVA analysis forrepeated measures, with factors of variation being time (before vs.after treatment) and treatment (placebo vs. crystal insoles). Whenstatistical significance was reached, multiple comparisons wereperformed using the Student-Newman-Keuls method. P<0.05 was consideredstatistically significant.

Results and discussion

A total of 35 patients were included in the study and were randomizedinto a placebo group (11 patients) and a crystal insole group (24patients). As shown in FIG. 7, both groups had a similar initial score(mean+SEM: placebo 14.27±1.25 vs. crystals 14.38±0.85, NS). After 6weeks of treatment, the score was significantly improved in both groups.The score was decreased by 25% in the placebo group to 10.73±2.05(P<0.02), whereas it was decreased by 49% in the crystal insoles groupto 7.50±1.18 (P<0.01). The 49% improvement observed in the crystalinsoles group was statistically greater than the 25% improvementobserved in the placebo group (P<0.05).

These results show that the crystal containing insoles significantlyimproved the quality of life of patients with chronic back pain bydecreasing their disability condition by 49%. The observed placeboeffect (25%) is not surprising in such a clinical study where subjectiveparameters are measured such as pain, well-being or quality of life.This emphasizes the need to implement double-blind, placebo-controlledstudies to evaluate the clinical efficacy of new treatments for chronicback pain.

In conclusion, the crystal insoles are powerful tools that can be usedtherapeutically to improve the condition of patients with chronic backpain.

Although the invention has been described with respect to specificembodiments, it is understood that modifications are possible within thescope of the appended claims without departing from the spirit of theinvention.

We claim:
 1. Pedal device for treating and preventing physical troublesassociated with statural disequilibrium, which comprises an articleadapted to contact a sole of a foot, characterized in that said articleincorporates at least a crystalline substance having a color by emittingphotons in the wavelength range between about 400 nm and 900 nmstimulating reflex zones located at the sole of the foot.
 2. Pedaldevice according to claim 1, wherein said crystalline substance is inpowder form.
 3. Pedal device according to claim 1, wherein said articlecomprises an inner sole to be worn against said sole of a foot.
 4. Pedaldevice according to claim 3, wherein said inner sole is an inner sole ofa shoe.
 5. Pedal device according to claim 1, wherein said substance isplaced at the surface of said article.
 6. Pedal device according toclaim 1, wherein said article comprises two semi-rigid fabric layersbonded together, said substance being inserted between said layers ofsaid foot sole.
 7. Pedal device according to claim 1, whereincrystalline substance is a mineral substance.
 8. Pedal device accordingto claim 1, wherein said crystalline substance is an organic substance.9. Pedal device according to claim 7, wherein said mineral substance isselected from the group consisting of crystals and powders selected fromelements, natural and synthetic sulfides and sulfosalts, natural andsynthetic halides, natural and synthetic oxides and hydroxides, naturaland synthetic nitrates, carbonates and borates, natural and syntheticsulfates, chromates, molybdates and tungstates, natural and syntheticphosphates, arseniates, and vanadates, natural and synthetic silicates,and natural and organic substances.
 10. Pedal device according to claim7, wherein said mineral substance is selected from the group consistingof sulphur powders.
 11. Pedal device according to claim 7 or 8, whereinsaid crystalline substance is a combination of substances having atleast one of the following different colors: red, orange, yellow, green,blue, purple and white.
 12. Pedal device according to claim 7, whereinsaid mineral substance is selected from the group consisting of jasper,cornelian, topaz safranite, aventurine, azurite, amethyst and quartz andmixtures thereof.
 13. Pedal device according to claim 7, wherein saidmineral substance is disposed between said layers as a plurality oftransverse bands of said mineral substances.
 14. Pedal device accordingto claim 1, wherein said substance is disposed at a surface of saidarticle which is in contact with said sole foot.
 15. Pedal deviceaccording to claim 11, wherein said mineral substance comprises powderedsulphur, said powdered sulphur being incorporated between said fabriclayers in amount between about 5 mg to 30 g, at the level of an arch ofsaid foot sole.
 16. Pedal device according to claim 15, wherein saidcrystalline substance comprises a mixture of sulphur powder, red jasper,orange cornelian, yellow topaz safranite, green aventurine, blueazurite, purple amethyst and white quartz.
 17. The use of a pedal deviceto improve the condition of patients suffering from musculoskeletalpain, which comprises placing a pedal device according to claim 1 at oneor both feet of said patient.
 18. The use of claim 17, wherein themusculoskeletal pain is chronic back pain.
 19. The use of claim 17,wherein the musculoskeletal pain is associated with staturaldisequilibrium.
 20. The use of claim 17, wherein said pedal device isapplied directly to skin of said sole foot.
 21. The use of claim 17,wherein said pedal device is placed over socks or stockings worn by saidpatient.
 22. The use of a pedal device to improve muscle strength andphysical performance which comprises placing a pedal device according toclaim 1 at one or both feet of a person.
 23. The use of claim 22,wherein said person is in need of correction of statural disequilibrium.24. The use of a pedal device to induce stress relief which comprisesplacing a pedal device according to claim 1 at one or both feet of aperson.
 25. The use of claim 24, wherein said person is in need ofcorrection of statural disequilibrium.